安微医科大学国际教育学院教案与讲稿 1.Principle of Clinical Pharmacology(Second Edition);ArthurJ.Atkinson Reference 2.Basic Clinical Pharmacology;Bertram G.Katzung Text 3.Oxford Textbook of Clinical Pharmacology and Drug Therapy;David Grahame-Smith,Jeffrey Aronson Memo Teaching Plan for International Students,AHMU Title of the course:New drugs development Chapter:One Teacher's name: Associate Prof.Lingling Zhang Grade:2013 Department:Clinical Medicine,School of International Education Time:14:30-16:50 Date(DM/Y):4/6/2016 Lecture Notes: [MODULES] 5min MODULE 1:Preclinical development of new drugs MODULE 2:GCP and the significance of implementing GCP MODULE 3:Phase I clinical trial:tolerance test and pharmacokinetic studies MODULE 4:Phase II clinical trial MODULE 5:Phase III clinical trial and Phase IV clinical trial MODULE 6:Drug bioequivalence test [The definition of drugs and new drugs] 5 min 1.Drugs:The drugs are some materials,which are used for the prevention,treatment and diagnosis of diseases,regulating physiological function,and having indications,major functions and usage. 2.New drugs:new drugs are the drugs that are not posted in state pharmacopoeia()or approved to be of used by the state department of pharmaceutical administration. [Preclinical drug development includes four areas] 2min Preclinical development encompasses(all of the activities that must take place before a new chemical entity can be administered to humans. Generally,: (1)Vitro studies (2)Drug supply and manufacturing, (3)Drug formulation, (4)Vivo studies in animal models. [In Vitro Studies] 5min (1)Vitro screening assays include the ability of drugs: To bind to receptors, To inhibit specific enzymes, To stabilize or destabilize multi protein complexes. In vitro assessment can be performed in intact cell lines 2安徽医科大学国际教育学院教案与讲稿 2 Reference Text 1. Principle of Clinical Pharmacology (Second Edition); ArthurJ. Atkinson 2. Basic & Clinical Pharmacology; Bertram G. Katzung 3.Oxford Textbook of Clinical Pharmacology and Drug Therapy; David Grahame-Smith, Jeffrey Aronson Memo Teaching Plan for International Students, AHMU Title of the course: New drugs development Chapter: One Teacher’s name: Associate Prof. Lingling Zhang Grade: 2013 Department: Clinical Medicine, School of International Education Time: 14:30—16:50 Date (D/M/Y): 4/6/2016 Lecture Notes: [MODULES] 5min MODULE 1: Preclinical development of new drugs MODULE 2: GCP and the significance of implementing GCP MODULE 3: PhaseⅠ clinical trial：tolerance test and pharmacokinetic studies MODULE 4: Phase II clinical trial MODULE 5: Phase III clinical trial and Phase IV clinical trial MODULE 6: Drug bioequivalence test [The definition of drugs and new drugs] 5 min 1.Drugs:The drugs are some materials, which are used for the prevention, treatment and diagnosis of diseases, regulating physiological function, and having indications, major functions and usage. 2.New drugs: new drugs are the drugs that are not posted in state pharmacopoeia(药典） or approved to be of used by the state department of pharmaceutical administration. [Preclinical drug development includes four areas] 2min Preclinical development encompasses（包含）all of the activities that must take place before a new chemical entity can be administered to humans. Generally,： (1) Vitro studies (2) Drug supply and manufacturing, (3) Drug formulation, (4) Vivo studies in animal models. [In Vitro Studies] 5min (1) Vitro screening assays include the ability of drugs: To bind to receptors, To inhibit specific enzymes, To stabilize or destabilize multi protein complexes. In vitro assessment can be performed in intact cell lines